Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT01233648

First received: November 2, 2010

Last updated: November 21, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 2010

Last Updated Date

November 21, 2011

Start Date ^ICMJE

June 2006

Estimated Primary Completion Date

November 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

AF burden [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01233648 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)

Official Title ^ICMJE

Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)

Brief Summary

This study is being done to find out if controlling rate or controlling rhythm is better for heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device and AV node ablation as part of their clinical care will be followed for one year. One group will have their heart rate controlled by the ICD and AVN ablation alone and the second group will be treated with the ICD, AVN ablation and standard medical therapies to restore the heart's normal rhythm. The study doctors will compare the information collected from all of the subjects in this study to see if treating rate or treating rhythm is better in patients with heart failure and AF, resulting in a better quality of life.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Other: rate control via CRT-D and AVN ablation
rate control
Other: rhythm control via pharmacologic, electrical or ablative therapies
rhythm control

Study Arm (s)

Active Comparator: AF
Intervention: Other: rate control via CRT-D and AVN ablation
Active Comparator: SR
Intervention: Other: rhythm control via pharmacologic, electrical or ablative therapies

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

December 2016

Estimated Primary Completion Date

November 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Having persistent AF, defined as AF that does not self terminate for at least 24 consecutive hours.
In AF upon entry into the operating room for CRT-D implantation and AV node ablation.
Being on a stable dosage of an ACE inhibitor or ARB for at least 1 month preceding implant
Being on a Beta-blocker for at least 3 months preceding implant and a stable dosage within 1 month of implant
Not taking or able to be taken off all type I/III antiarrhythmic medications.
Taking Coumadin so as to maintain an INR of between 2 and 3.
A Class I or IIa ICD indication
NYHA Class III/IV within 1 month of baseline
Intrinsic QRS duration ≥ 130 ms within 1 month prior to baseline
Left ventricular ejection fraction ≤ 35% (method per physician discretion) within 1 month prior to baseline
Left ventricular end diastolic dimension (LVEDD) ≥ 55 mm (method per physician discretion) within 1 months prior to baseline
Willing to provide written informed consent
Are expected to survive for 6 month of study participation
Able to tolerate an urgent thoracotomy
Able to tolerate < 1 mg dexamethasone sodium phosphate (steroid)

Exclusion Criteria:

Having self-terminating or interminable AF
Having unstable angina, or having experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within the past 1 month
Post-heart transplant (patients on heart transplant list for the first time are not excluded)
Having mechanical right heart valve
Having an existing CRT or atrial therapy device(s)
Being enrolled in any concurrent drug and/or device study which would confound the results of this trial
Having primary valvular disease and indicated for valve repair or replacement
Having a previous AV node ablation
Being on a Type I or Type III anti-arrhythmic medication for the treatment of ventricular tachyarrhythmias
Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01233648

Other Study ID Numbers ^ICMJE

0601113

Has Data Monitoring Committee

Not Provided

Responsible Party

University of Pittsburgh

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David S. Schwartzman, MD

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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